The following data is part of a premarket notification filed by Microlife Corp. with the FDA for Microlife Digital Basal Thermometer, Model Mt 1921.
| Device ID | K030961 |
| 510k Number | K030961 |
| Device Name: | MICROLIFE DIGITAL BASAL THERMOMETER, MODEL MT 1921 |
| Classification | Device, Fertility Diagnostic, Proceptive |
| Applicant | MICROLIFE CORP. 55 Northern Blvd. Suite 200 Great Neck, NY 11021 |
| Contact | Susan D Goldstein-falk |
| Correspondent | Susan D Goldstein-falk MICROLIFE CORP. 55 Northern Blvd. Suite 200 Great Neck, NY 11021 |
| Product Code | LHD |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-03-27 |
| Decision Date | 2003-09-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00634782564315 | K030961 | 000 |